Eustachian tube modification

ABSTRACT

Disclosed embodiments relate to devices, systems, and methods of shaping, shrinking, opening, dilating, stiffening, or otherwise modifying a Eustachian tube and its surrounding tissue in order to improve the Eustachian tube&#39;s function. For example, patients with blocked, closed, or hypertrophic Eustachian tubes may be able to achieve improved function including easier equalization of pressure between the inner ear and environment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 62/303,711, titled “Eustachian Tube Modification,” filed on Mar. 4,2016. The disclosure of this priority application is hereby incorporatedby reference in its entirety herein.

FIELD

This application generally relates to the field of medical devices andtreatments, and in particular to systems, devices and methods fortreating a Eustachian tube and/or surrounding tissue.

BACKGROUND

As shown in FIG. 1, the Eustachian tube (sometimes referred to as theauditory tube or the pharyngotympanic tube) is a tube that connects thetympanic cavity of the middle ear to the nasopharynx. At thenasopharynx, the Eustachian tube is bounded by the torus of theEustachian tube and forms the pharyngeal opening of the Eustachian tube(also known as the pharyngeal ostium). The Eustachian tube includes acartilaginous portion and an osseous (bone) portion. There are severalmuscles that affect the function of the Eustachian tube, includingmuscles of the soft palate (e.g., the levator veli palatini and tensorveli palatini) and muscles of the ear (e.g., tensor tympani).

Dysfunction of the Eustachian tube (e.g., caused by inflammation of thetissue of or near the Eustachian tube) may result in Eustachian tubeblockage and/or cause the Eustachian tube to resist opening. This mayresult in undesirable pressure changes and fluid collection in themiddle ear. This can result in discomfort and may cause ear infections.While sometimes dysfunction of the Eustachian tube may resolve on itsown or with minimal intervention, sometimes greater intervention isrequired. Some methods require modifying the ear drum or installing aprosthesis in the Eustachian tube or surrounding tissue. Current methodshave drawbacks relating to patient discomfort and ineffectiveness. Forexample, implantable tubes often hold the Eustachian tube in analways-open state, which may be very distracting and uncomfortable forpatients. Further, implantable tubes or surgical intervention canrequire general anesthesia, invasive surgical access, and othercomorbidities.

Therefore, a need exists for improved methods, systems, and devices formodifying a patient's Eustachian tube to help treat Eustachian tubemalfunction. Ideally, such methods, systems, and devices would beminimally invasive or less invasive than currently available methods.Also ideally, such methods, systems, and devices would not result in apermanently open Eustachian tube. The embodiments described herein arerelevant to achieving at least some of these objectives.

BRIEF SUMMARY

Embodiments of the present application are relevant to devices, systems,and methods for the treatment of Eustachian tubes. An example method mayinclude contacting an elongate treatment element of a treatment deviceagainst or in proximity to the Eustachian tube. Example methods mayfurther include applying energy using the elongate treatment element,thereby modifying the Eustachian tube. Example methods may furtherinclude the Eustachian tube retaining the modification after theelongate treatment element is removed.

In one aspect, a method of treating a Eustachian tube may involve:contacting an elongate treatment element of a treatment device withtissue in or near the Eustachian tube; and applying energy to orremoving energy from at least one of the tissue or an underlying tissuebeneath the tissue, using the elongate treatment element, to modify atleast one property of the Eustachian tube, thereby treating theEustachian tube. The at least one property of the Eustachian tube mayremain at least partially modified after the treatment.

In various embodiments, the applying energy using the elongate treatmentelement may include applying bipolar radiofrequency energy. In someembodiments, applying energy using the elongate treatment elementincludes applying bipolar radiofrequency energy to mucosa near an ostiumin a nasopharynx. In some embodiments, the at least one propertyincludes an amount of contraction the muscles of the Eustachian tuberequire to open the Eustachian tube. In some embodiments, the method mayfurther involve applying sufficient force to the tissue with thetreatment element to temporarily reshape the tissue at least one ofbefore, during or after applying the energy. In some embodiments, theelongate treatment element has a convex tissue treatment surface; andforce is applied to the tissue with the convex tissue treatment surfaceto cause the tissue to assume a concave shape. In some embodiments,contacting the elongate treatment element includes contactingatraumatic, rounded electrodes on a tissue treatment surface of thetreatment element with the tissue.

In another aspect, a method of modifying a Eustachian tube may involve:contacting an elongate treatment element of a treatment device againstmucosa of the patient's nasopharynx; and applying energy to or removingenergy from the mucosa or tissue underlying the mucosa, thereby causinga modification of the Eustachian tube. The Eustachian tube may at leastpartially maintain the modification after the treatment element isremoved and the mucosa or tissue underlying the mucosa heals.

In some embodiments, applying energy to or removing energy from themucosa or tissue underlying the mucosa further involves: applying energyto the tissue underlying the mucosa; and removing energy from themucosa. In some embodiments, removing energy from the mucosa furtherincludes cooling the mucosa using a cooling mechanism of the treatmentelement. In some embodiments, applying energy to the tissue underlyingthe mucosa involves injuring the tissue underlying the mucosa. In someembodiments, contacting the treatment element of the treatment deviceagainst mucosa of the patient's nasopharynx involves contacting thetreatment device against the mucosa with sufficient force to alter ashape of the mucosa. In some embodiments, applying energy includesapplying radiofrequency energy. In some embodiments, the mucosa is neara pharyngeal opening of the Eustachian tube. In some embodiments, thetissue underlying the mucosa includes one or more of cartilage of theEustachian tube, bone of the Eustachian tube, the torus of theEustachian tube, muscles that affect the function of the Eustachiantube, muscles of the soft palate, levator veli palatini muscle, tensorveli palatini muscle, muscles of the ear, and the tensor tympani muscle.In some embodiments, modifying the Eustachian tube includes shaping,shrinking, opening, dilating, or stiffening the Eustachian tube.

In another aspect, a method of modifying a Eustachian tube, includespositioning a treatment element within a patient's nasopharynx adjacentto target tissue to be treated; and delivering radiofrequency energy tothe electrode to heat the target tissue, thereby modifying a property ofthe target tissue and a property of the Eustachian tube. In someembodiments, the treatment element has a convex treatment surface and anelectrode. In some embodiments, the property of the target tissue andthe property of the Eustachian tube remain at least partially modifiedafter the treatment element is removed.

In some embodiments, delivering radiofrequency energy includesdelivering radiofrequency energy to at least one of: cartilage of theEustachian tube, bone of the Eustachian tube, the patient's upperairway, the patient's nose, the patient's pharyngeal opening of theEustachian tube, the patient's torus of the Eustachian tube, musclesthat affect the function of the Eustachian tube, muscles of thepatient's soft palate, a levator veli palatini muscle, a tensor velipalatini muscle, muscles of the patient's ears, and a tensor tympanimuscle. In some embodiments, the method further includes cooling thetarget tissue or tissue near the target tissue before, during, or afterdelivering the radiofrequency energy. In some embodiments, deliveringradiofrequency energy includes delivering radiofrequency energy forabout 15 seconds to about 1 minute. In some embodiments, deliveringradiofrequency includes heating an area of tissue around the electrodeto a temperature of about 50 degrees C. to about 70 degrees C. In someembodiments, positioning the treatment element includes applying forceto a tissue of the patient's nasopharynx.

In another aspect, a method of treating a Eustachian tube having apharyngeal ostium, the method includes: positioning an array of energydelivery elements of a treatment element around the pharyngeal ostium;and applying energy using the energy delivery elements to modify thetissue of the ostium, surrounding mucosa, or surrounding submucosa. Insome embodiments, positioning an array of energy delivery elementsaround the pharyngeal ostium includes inserting a flexible probe intothe pharyngeal ostium, thereby aligning the array of energy-deliveryelements around the pharyngeal ostium.

In another aspect, a device for modifying a Eustachian tube has: ashaft; a treatment portion extending from a distal end of the shaft, thetreatment portion having an arcuate tissue treatment surface; a firstarcuate row of electrodes disposed on the arcuate tissue treatmentsurface; a second arcuate row of electrodes disposed on the tissuetreatment surface; and a thermocouple disposed between the first arcuaterow and the second arcuate row.

In some embodiments, the device may further include a passive positionerextending from the treatment portion. In some embodiments, the passivepositioner component is sized and shaped to be inserted into an openingof the Eustachian tube to facilitate positioning the one or moreelectrodes relative to the opening. In some embodiments, the passivepositioner includes a flexible elongate protrusion having a bulb at adistal end of the protrusion. In some embodiments, one or moreelectrodes are disposed on the passive positioner for treatment withinthe Eustachian tube. In some embodiments, the one or more electrodesdisposed on the treatment surface include multiple electrodes disposedon the treatment surface circumferentially around the passivepositioner. In some embodiments, the shaft is an elongate, flexibleshaft sized and shaped to be inserted through a patient's nostril toreach the opening of the Eustachian tube. In some embodiments, thepassive positioner has an expandable balloon configured to be expandedafter the passive positioner is inserted into the Eustachian tube tofacilitate positioning or anchoring the device relative to the openingof the Eustachian tube. In some embodiments, the electrodes of the firstrow and the electrodes of the second arcuate row comprise elongate,blunt-tipped electrodes extending away from the tissue treatmentsurface.

These and other aspects and embodiments will be described in furtherdetail below, in reference to the attached drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an ear, including the middle ear and Eustachian tube.

FIG. 2 illustrates an example method of modifying a Eustachian tube.

FIG. 3 depicts a schematic illustration of a treatment device accordingto some embodiments.

FIGS. 4A and 4B depict embodiments of various electrode arrangements forapplying energy to tissue.

FIGS. 5A and 5B illustrate embodiments of devices for applying energy totissue using a monopolar electrode.

FIG. 6 shows an embodiment of a device for applying energy to tissueincluding an array of non-penetrating electrodes.

FIGS. 7A and 7B illustrate an embodiment of a device for applying energyto tissue.

FIGS. 8A and 8B illustrate an embodiment of a device for applying energyto tissue.

FIGS. 9A and 9B illustrate an embodiment of a device for applying energyto tissue, the device having a symmetrical shape.

FIGS. 10A-10G illustrate an embodiment of a device for applying energyto tissue using a monopolar electrode.

FIGS. 11A-11G illustrate an embodiment of a device for applying energyto tissue using an array of needle electrodes.

FIG. 12A illustrates a cross-section of tissue.

FIG. 12B illustrates heat effects of RF treatment of tissue.

FIGS. 13A and 13B illustrate embodiments of devices for applying energyto tissue, the devices incorporating cooling systems.

FIG. 14 shows an embodiment of a device for applying energy to tissue,the device incorporating a heat pipe.

FIG. 15 shows an embodiment of a system including a device for applyingenergy to tissue, the device including electrode needles and a separatecooling mechanism.

FIGS. 16A-16C illustrate an embodiment of a method for treating aEustachian tube.

FIG. 17 illustrates an embodiment of a method for treating a Eustachiantube.

FIG. 18 illustrates an embodiment of a method for treating a Eustachiantube.

FIGS. 19A and 19B illustrate an embodiment of a device and method fortreating a Eustachian tube.

FIGS. 20A-20D illustrate an embodiment of a device having an arcuatetreatment element for treating a Eustachian tube.

FIGS. 21A and 21B are a perspective view and a side, cross-sectionalview, respectively, of an embodiment of a device for applying energy totissue, the device including an internal power source.

FIG. 22 is a bottom view of a distal end of a treatment device,illustrating wings of the treatment device that may be used to helpguide the distal end to a desired location.

FIGS. 23A-23C are top views of various alternative embodiments of distalends of treatment devices having different shapes for addressingdifferently shaped tissues.

DETAILED DESCRIPTION

Disclosed systems, methods, and devices may be used to modify aEustachian tube of a patient. In some embodiments, a device may be usedto shape, shrink, open, dilate, stiffen, or otherwise modify theEustachian tube or surrounding tissue in order to improve the Eustachiantube's function. In some embodiments, modifying the Eustachian tubeincludes causing a change in the Eustachian tube or surrounding tissuethat makes the Eustachian tube easier to open. In some embodiments,modifying the Eustachian tube includes changing the shape of theEustachian tube.

In some embodiments, some treatment methods may include applyingtreatments selected to change mechanical or structural properties of thetreated tissue. In some embodiments, such treatments may includeapplication of energy to, or removal of energy from, target tissue. Someembodiments may include injecting bulking agents, glues, polymers,collagen and/or other allogenic or autogenic tissues, or growth agents.

Embodiments may include a treatment element that is held against or inproximity to the Eustachian tube and/or surrounding tissue and used tomodify the tissue. In one embodiment, a device or system applies bipolarradiofrequency energy to the mucosa near an ostium of the Eustachiantube in the nasal cavity to heat, shrink, and/or stiffen the tissue,thus allowing the muscles of the Eustachian tube to require lesscontraction in order to open the tube. In another embodiment, the devicemay have a cryogenic treatment element. The device may treat a portionof the ostium or the entire ostium at once with an array of electrodes.In some embodiments, an energy-modifying balloon may treat the ostium orEustachian tube. In some embodiments, electrodes delivering monopolar orbipolar energy are atraumatic, rounded electrodes that press against thetarget tissue. In some embodiments, electrodes are needles thatpenetrate the mucosa.

While the Eustachian tube may be directly modified in some embodiments,alternative devices, systems, and methods may indirectly target theEustachian tube by modifying tissues that are associated with theEustachian tube (e.g., surrounding tissues). For example, the tensorveli palatini muscle connects to the lateral wall of cartilage of theEustachian tube. Some embodiments may treat the tensor veli palatinimuscle to cause a change in the function of the Eustachian tube, withoutdirectly modifying the Eustachian tube. In some embodiments, disclosedmethods may be applied without requiring general anesthesia. Thetreatment element may be configured to be inserted through the nostrilto the treatment area. In some embodiments, treatment is applied withoutincisions, dissections and/or other significant trauma.

Example Method of Modifying the Eustachian Tube

FIG. 2 illustrates an example method 10 to modify a Eustachian tube andsurrounding tissue. The example method 10 may include one or more stepsor actions as illustrated by one or more of blocks 12 and/or 14. Theoperations or actions described in the blocks 12, 14 may be performed bya healthcare provider or other person and may include using systems anddevices disclosed herein or elsewhere.

An example method may begin with block 12, which recites “contactingtarget tissue with treatment element.” Block 12 may be followed by block14, which recites “applying energy to or removing energy from atreatment target to modify a Eustachian tube or surrounding tissue.” Theblocks included in the described example methods are for illustrationpurposes. In alternative embodiments, the various blocks may be dividedinto additional blocks, supplemented with other blocks, or combinedtogether into fewer blocks. Other variations of these specific blocksare contemplated, including changes in the order of the blocks, changesin the content of the blocks being split or combined into other blocks,and so on.

Block 12 recites “contacting target tissue with treatment element.” Thetarget tissue may be any tissue at or through which energy can beapplied to or removed from in order to modify a Eustachian tube orsurrounding tissue (see block 14). In some embodiments, the targettissue may be any tissue (e.g., skin, mucosa, submucosa, cartilage,bone, or other tissue) at, near, or associated with: the ear, the earcanal, the middle ear, the tympanic cavity of the middle, the Eustachiantube, cartilage of the Eustachian tube, bone of the Eustachian tube, theupper airway, the nose, the nasopharynx, the pharyngeal opening of theEustachian tube, the torus of the Eustachian tube, muscles that mayaffect the function of the Eustachian tube, muscles of the soft palate,levator veli palatini muscle, tensor veli palatini muscle, muscles ofthe ear, the tensor tympani muscle, and others.

In some embodiments, block 12 further includes accessing the targettissue. For example, in some embodiments, the target tissue may locatedat or near the nasopharynx and block 12 may further include inserting atreatment element of a device through a patient's nostril and placingthe treatment element at the target tissue within the nasopharynx. Asanother example, in some embodiments, the target tissue may be locatedwithin the middle ear or the Eustachian tube itself and block 12 mayfurther include inserting a treatment element of a device through apatient's ear canal to a target treatment site. This may further includeinserting a treatment element of a device through the patient's ear drumto a target site within the middle ear and/or Eustachian tube.

As a further example, in some embodiments, block 12 may further includecreating an incision or other opening in particular tissue and insertingthe treatment element through the incision or opening to access a deeperlayer of tissue. This may include, for example, creating a perforationin an ear drum and inserting a treatment element to access an inner ear.As another example, this may include creating an incision in mucosa orother tissue and contacting the treatment element against the deeperlayer of tissue, such as muscle and/or connective tissue that helps theEustachian tube open or contract. In some embodiments, the device itselfincludes a cutting element for creating its own incisions.

Block 14 recites “applying energy to or removing energy from a treatmenttarget to modify a Eustachian tube or surrounding tissue.” In someembodiments, energy may be applied in the form of heat, radiofrequency(RF), laser, light, ultrasound (e.g., high intensity focusedultrasound), microwave energy, electromechanical, mechanical force,cooling, alternating or direct electrical current (AC or DC current),chemical, electrochemical, or others. Alternative embodiments mayinclude removing energy from a treatment target by, for example,applying cryogenic therapy. Some embodiments may include both applyingenergy to and removing energy from tissue.

Any one or more of the above energy-application mechanisms may also beused to reshape, remodel, or change mechanical or physiologic propertiesof structures of a Eustachian tube or surrounding tissues. For example,in some embodiments, energy may be applied to a targeted region oftissue adjacent a Eustachian tube, such that the tissue modificationresults in a tightening, shrinking or enlarging of such targetedtissues, resulting in a modification of the Eustachian tube. In somesuch embodiments, reshaping of a Eustachian tube section may be achievedby applying energy without necessarily applying a mechanical reshapingforce. For example energy can be used to selectively shrink tissue inspecific locations of the Eustachian tube or surrounding tissues thatwill lead to a controlled conformational change.

In alternative embodiments, strengthening and/or conformation change(e.g., reshaping) of a Eustachian tube or surrounding tissues mayinclude modification of tissue growth and/or the healing and fibrogenicprocess. For example, in some embodiments energy may be applied to atargeted tissue at or near the Eustachian tube in such a way that thehealing process causes a change to the shape of the Eustachian tubeand/or a change in the structural properties of the tissue. In someembodiments, such targeted energy application and subsequent healing maybe further controlled through the use of temporary implants or reshapingdevices (e.g. internal stents or molds, or external adhesive strips).

In some embodiments, energy may be delivered into the tissue to cause aconformational change and/or a change in the physical properties of thetissue. Energy delivery may be accomplished by transferring the energythrough tissue, including but not limited to epithelium, mucosa,sub-mucosa, muscle, ligaments, tendon and/or skin. In some embodiments,energy may also be delivered to tissue using needles, probes ormicroneedles that pass through tissue (e.g., epithelium, mucosa,submucosa, muscle, ligaments, tendon and/or skin). The treatment elementmay be used to deform tissue into a desired shape by pressing a convexsurface of the treatment element against the tissue to be treated.

A control input such as a button may be used to activate the electrodeand deliver energy (e.g., RF energy) to the tissue to be treated. Insome embodiments, temperature of the area around an electrode duringtreatment is from about 30 degrees Celsius to about 90 degrees Celsius.In some embodiments, temperature of the area around the electrode duringtreatment is from about 40 degrees Celsius to about 80 degrees Celsius.In some embodiments, temperature of the area around the electrode duringtreatment is from about 50 degrees Celsius to about 70 degrees Celsius.In some embodiments, temperature of the area around the electrode duringtreatment is about 60 degrees Celsius. In some embodiments, for exampleduring cryotherapy, temperature of the area around the electrode may belower.

In some embodiments, treating the target tissue includes treatment forabout 10 seconds to about 3 minutes. In some embodiments, treating thetarget tissue includes treatment for about 10 seconds to about 2minutes. In some embodiments, treating the target tissue includestreatment for about 15 seconds to about 1 minute. In some embodiments,treating the target tissue includes treatment for about 20 seconds toabout 45 seconds. In some embodiments, treating the target tissueincludes treatment for about 30 seconds.

In some embodiments, treating the target tissue includes deliveringbetween about 1 and about 100 watts to the tissue. In some embodiments,treating the target tissue includes delivering between about 5 watts andabout 75 watts to the tissue. In some embodiments, treating the targettissue includes delivering between about 10 watts and about 50 watts tothe tissue.

In an embodiment, the method 10 may further include identifying apatient who may benefit from modification of the Eustachian tube and/orsurrounding tissue.

In an embodiment, the method may further include positioning the patienteither in an upright position (e.g., seated or standing) or lying down.Local anesthesia may be applied to an area near or surrounding thetissue to be treated. General anesthesia may also be used.

In an embodiment, the method may further include using a positioningelement to measure a desired depth or angle of treatment. Thepositioning element may be inserted to the desired depth of treatmentand rotated to a desired angle of treatment. Marks along the positioningelement can indicate the desired depth. Marks along the base of theshaft of the positioning element can indicate the desired angle. Thephysician can then insert the treatment device to the desired location.The physician may also assess any other characteristics relevant to thetreatment of the patient's ear, nasopharynx, Eustachian tube and/orsurrounding tissue that may influence the manner of treatment. In someembodiments, a reshaping element may be used to manipulate tissue into aconfiguration allowing improved Eustachian tube function; and treatmentmay be performed while such a reshaping element is maintaining thedesired configuration of the Eustachian tube and/or surrounding tissue.

Example Treatment Device

FIG. 3 illustrates an embodiment of a treatment device 30. The device 30includes a treatment element 32 which may be configured to be placed ator near a target tissue to be treated. For example, the device 30 or aportion thereof may be configured to be placed inside a patient'spharynx, nasopharynx, nasal cavity, nasal passage, nasal airway, airway,and/or ear canal to deliver desired treatment. In some embodiments, thedevice 30 may further include a handle section 34 which may be sized andconfigured for easy handheld operation by a clinician. In someembodiments, a display 36 may be provided for displaying information toa clinician during treatment.

In some embodiments, the information provided on the display 36 mayinclude treatment delivery information (e.g. quantitative informationdescribing the energy being delivered to the treatment element) and/orfeedback information from sensors within the device and/or within thetreatment element. In some embodiments, the display may provideinformation on physician selected parameters of treatment, includingtime, power level, temperature, electric impedance, electric current,depth of treatment and/or other selectable parameters.

In some embodiments, the handle section 34 may also include inputcontrols 38 (e.g., buttons, knobs, dials, touchpad, joystick, etc.). Insome embodiments, controls may be incorporated into the display, such asby the use of a touch screen. In further embodiments, controls may belocated on an auxiliary device which may be configured to communicatewith the treatment device 30 via analog or digital signals sent over acable 40 or wirelessly, such as via Bluetooth, Wi-Fi, infrared or anyother wired or wireless communication method.

In some embodiments the treatment system may include an electroniccontrol system 42 configured to control the timing, location, intensityand/or other properties and characteristics of energy or other treatmentapplied to targeted regions of a Eustachian tube or surrounding tissues.In some embodiments, a control system 42 may be integrally incorporatedinto the handle section 34. Alternatively, the control system 42 may belocated in an external device which may be configured to communicatewith electronics within the handle section 34. A control system mayinclude a closed-loop control system having any number of sensors, suchas thermocouples, electric resistance or impedance sensors, ultrasoundtransducers, or any other sensors configured to detect treatmentvariables or other control parameters.

The treatment system may also include a power supply 44. In someembodiments, a power supply may be integrally incorporated within thehandle section 34. In alternative embodiments, a power supply 44 may beexternal to the handle section 34. An external power supply 44 may beconfigured to deliver power to the handle section 34 and/or thetreatment element 32 by a cable or other suitable connection. In someembodiments, a power supply 44 may include a battery or other electricalenergy storage or energy generation device. In other embodiments, apower supply may be configured to draw electrical power from a standardwall outlet. In some embodiments, a power supply 44 may also include asystem configured for driving a specific energy delivery technology inthe treatment element 32. For example, the power supply 44 may beconfigured to deliver a radio frequency alternating current signal to anRF energy delivery element. Alternatively, the power supply may beconfigured to deliver a signal suitable for delivering ultrasound ormicrowave energy via suitable transducers. In further alternativeembodiments, the power supply 44 may be configured to deliver ahigh-temperature or low-temperature fluid (e.g., air, water, steam,saline, or other gas or liquid) to the treatment element 32 by way of afluid conduit.

In some embodiments, the treatment element 32 may have a substantiallyrigid or minimally elastic shape sized and shaped such that itsubstantially conforms to an ideal shape and size for treating targettissue to cause a modification of the Eustachian tube or surroundingtissues. In some embodiments, the treatment element 32 may have a curvedshape, either concave or convex with respect to a wall of as patient'snasopharynx. In some embodiments, the shape of a fixed-shape treatmentelement may be substantially in a shape to be imparted to the targettissue. In some embodiments, the treatment element may be sized and/orshaped to be inserted through a patient's nostril, ear canal, ear drum,and/or other area in order to access a treatment area.

In some embodiments, as shown for example in FIG. 3, the treatmentelement 32 may include a substantially cylindrical central portion witha semi-spherical or semi-ellipsoid or another shaped end-cap section atproximal and/or distal ends of the treatment element 32. In alternativeembodiments, the treatment element may include a substantially ellipsoidshape. In some embodiments, an ellipsoid balloon may have anasymmetrical shape. In alternative embodiments, the treatment element 32may have an asymmetrical “egg-shape” with a large-diameter proximal endand a smaller-diameter distal end. In some embodiments, the element 32can be shaped so as to impart a shape to the tissue to be treated. Anysuitable solid or expandable medical balloon material and constructionavailable to the skilled artisan may be used.

In some embodiments, the treatment element 32 may be configured todeliver heat energy to the Eustachian tube or surrounding tissues. Insuch embodiments, the treatment element may include any suitable heatingelement. For example, the treatment element 32 may include electricalresistance heating elements. In alternative embodiments, the heatingelement may include conduits for delivering high-temperature fluids(e.g. hot water or steam) onto the Eustachian tube or surroundingtissues. In some embodiments, a high-temperature fluid heating elementmay include flow channels which place high-temperature fluids intoconductive contact with Eustachian tube or surrounding tissues withoutsuch fluids directly contacting tissue of the patient. In furtherembodiments, any other suitable heating element may be provided. Infurther embodiments, the treatment element 32 may include elements fordelivering energy in other forms such as light, laser, RF, microwave,cryogenic cooling, DC current and/or ultrasound in addition to or inplace of heating elements.

U.S. Pat. No. 6,551,310 describes embodiments of endoscopic treatmentdevices configured to ablate tissue at a controlled depth from within abody lumen by applying radio frequency spectrum energy, non-ionizingultraviolet radiation, warm fluid or microwave radiation. U.S. Pat. No.6,451,013 and related applications referenced therein describe devicesfor ablating tissue at a targeted depth from within a body lumen.Embodiments of laser-treatment elements are described for example inU.S. Pat. No. 4,887,605, among others. U.S. Pat. No. 6,589,235 teachesmethods and device for cartilage reshaping by radiofrequency heating.U.S. Pat. No. 7,416,550 also teaches methods and devices for controllingand monitoring shape change in tissues, such as cartilage. The devicesdescribed in these and other patents and publications available to theskilled artisan may be adapted for use in treating portions of aEustachian tube or surrounding tissues as described herein. U.S. Pat.Nos. 7,416,550, 6,589,235, 6,551,310, 6,451,013 and 4,887,605 are herebyincorporated by reference in their entireties.

In alternative embodiments, similar effects can be achieved through theuse of energy removal devices, such as cryogenic therapies configured totransfer heat energy out of selected tissues, thereby lowering thetemperature of targeted tissues until a desired level of tissuemodification is achieved. Examples of suitable cryogenic therapydelivery elements are shown and described for example in U.S. Pat. Nos.6,383,181 and 5,846,235, the entirety of each of which is herebyincorporated by reference.

In some embodiments, the treatment element 32 may be configured todeliver energy (e.g. heat, RF, ultrasound, microwave) or cryotherapyuniformly over an entire outer surface of the treatment element 32,thereby treating all tissues in contact with the treatment element 32.Alternatively, the treatment element 32 may be configured to deliverenergy at only selective locations on the outer surface of the treatmentelement 32 in order to treat selected regions of tissues. In suchembodiments, the treatment element 32 may be configured so that energybeing delivered to selected regions of the treatment element can beindividually controlled. In some embodiments, portions of the treatmentelement 32 are inert and do not deliver energy to the tissue. In furtheralternative embodiments, the treatment element 32 may be configured withenergy-delivery (or removal) elements distributed over an entire outersurface of the treatment element 32. The control system 42 may beconfigured to engage such distributed elements individually or inselected groups so as to treat only targeted areas of the Eustachiantube or surrounding tissues.

In some embodiments, the treatment element 32 may be a balloon withenergy delivery elements positioned at locations where energy transferis sufficient or optimal to effect change in the Eustachian tube or itsfunction or its surrounding tissues. Such a balloon may be configured todeliver energy while the balloon is in an inflated state, therebyproviding a dual effect of repositioning tissue and delivering energy toeffect a change. In other embodiments, a balloon may also deliver heatby circulating a fluid of elevated temperature though the balloon duringtreatment. The balloon can also delivery cryotherapy (e.g. bycirculating a low-temperature liquid such as liquid nitrogen) while itis enlarged to alter the shape of a Eustachian tube or surroundingtissues.

Several embodiments may be employed for delivering energy treatment overa desired target area. For example, in some embodiments, a lasertreatment system may treat a large surface area by scanning a desiredtreatment pattern over an area to be treated. In the case of microwaveor ultrasound, suitably configured transducers may be positionedadjacent to a target area and desired transducer elements may beactivated under suitable depth focus and power controls to treat adesired tissue depth and region. In some embodiments, ultrasound and/ormicrowave treatment devices may also make use of lenses or other beamshaping of focusing devices or controls. In some embodiments, one ormore electrical resistance heating elements may be positioned adjacentto a target region, and activated at a desired power level for atherapeutically effective duration. In some embodiments, such heatingelements may be operated in a cyclical fashion to repeatedly heat andcool a target tissue. In other embodiments, RF electrodes may bepositioned adjacent to and in contact with a targeted tissue region. TheRF electrodes may then be activated at some frequency and power leveltherapeutically effective duration. In some embodiments, the depth oftreatment may be controlled by controlling a spacing between electrodes.In alternative embodiments, RF electrodes may include needles which maypuncture tissue to a desired depth.

In some embodiments, the treatment element 32 and control system 42 maybe configured to deliver treatment energy or cryotherapy to a selectedtissue depth in order to target treatment at specific tissues. Forexample, in some embodiments, treatments may be targeted at tighteningsections of the Eustachian tube or surrounding tissues. In otherembodiments, treatments may be targeted at strengthening tissues of thesoft palate to effect changes in the Eustachian tube and surroundingtissue. In further embodiments, treatments may be targeted atstrengthening cartilage the area of the Eustachian tube. In stillfurther embodiments, treatments may be targeted at stimulating ormodifying the tissue of muscles of the ear, soft palate, nose, face,and/or head in order to modify the Eustachian tube.

In some embodiments, the treatment element 32 and control system 42 maybe configured to deliver treatment energy to create specific localizedtissue damage or ablation, stimulating the body's healing response tocreate desired conformational or structural changes in the Eustachiantube or surrounding tissues.

In some embodiments, the treatment element 32 and control system 42 maybe configured to create specific localized tissue damage or ablationwithout the application of energy. For example the treatment element 32may be configured to chemically cauterize tissue by delivering acauterizing agent (e.g., silver nitrate, trichloroacetic acid,cantharidin, etc.) to the tissue. The treatment element 32 may includeapertures configured to permit the cauterizing agent pass through to thetarget tissue. In some embodiments, the treatment element 32 mayaerosolize the cauterizing agent. Other delivery methods are alsocontemplated. The treatment element 32 may include a lumen through whichthe cauterizing agent passes. The lumen may be fluidly connected to areservoir or container holding the cauterizing agent. The device mayinclude an input control (e.g., a button or switch) configured tocontrol the delivery of the cauterizing agent. In some embodiments, thetreatment element 32 includes an applicator that can be coated in acauterizing agent (e.g., dipped in a reservoir of cauterizing agent,swabbed with cauterizing agent, etc.) and the coated treatment elementapplicator may be applied to tissue to be treated. In some embodiments,the treatment element may be configured to apply cauterizing agent tothe patient over a prolonged period of time (e.g., 30 seconds, 1 minute,2 minutes, etc.). In some embodiment, the treatment element 32 includesshields configured to protect tissue surrounding the tissue to betreated from coming into contact with the cauterizing agent. In someembodiments, a separate element is used to shield tissue surrounding thetissue to be treated from coming into contact with the cauterizingagent. While such treatments may be performed without the application ofenergy, in some embodiments, they are performed in conjunction withenergy treatments.

In some embodiments, a treatment element may be configured to treat apatient's Eustachian tube or surrounding tissues by applying treatment(energy, cryotherapy, or other treatments) from a position outside thepatient's face and head. In some embodiments, a device may be configuredto apply energy from an element positioned externally to the patient,such as on the patient's skin. In another embodiment, a device may beplaced on the external surface of the patient that would pull skin,muscle, or other tissue to effect a change in the Eustachian tube orsurrounding tissues (e.g., a device for positioning the patient's jaw orear). Treatment may then be applied to the Eustachian tube orsurrounding tissues to achieve a desired Eustachian tube function.

In some embodiments, the device is configured to position tissue to bereshaped. In some embodiments, the device includes features andmechanisms to pull, push or position the tissue into a mold forreshaping. For example, suction, counter traction, or compressionbetween two parts of the device may be used.

In some embodiments, the treatment device includes one, two, three,four, or more molds configured to reshape tissue. The mold or reshapingelement may be fixed in size or may vary in size. The mold may also befixed in shape or may vary in shape. For example, the size or shape ofthe element may be varied or adjusted to better conform to an airway ofa patient. Adjustability may be accomplished using a variety of means,including, for example, mechanically moving the mold by way of joints,arms, guidewires, balloons, screws, stents, and scissoring arms, amongother means. The mold may be adjusted manually or automatically. Themold is configured to impart a shape to the Eustachian tube orsurrounding tissues area to improve actual or perceived Eustachian tubefunction.

In some embodiments, the mold or reshaping element includes a separateor integrated energy delivery or treatment element. The treatmentelement may be fixed or adjustable in size. For example, the treatmentelement may be adjusted to better conform to the tissue of a patient. Inthe case of a separate reshaping element and treatment element, adistance between the two elements may either be fixed or adjustable.Adjustability may be accomplished using a variety of means, including,for example, mechanically moving the mold by way of joints, arms,guidewires, balloons, screws, stents, and scissoring arms, among othermeans.

In some embodiments, the mold or another part of the device isconfigured to deliver cooling (discussed in more detail below). In someembodiments, the mold or reshaping element includes a balloon configuredto reshape and/or deform tissue. A balloon may also be configured todeliver energy such as heat using hot liquid or gas.

Modifications to the foregoing system and method will be understood fromthe following additional example systems, methods, and devices formodifying a Eustachian tube.

Examples of Various Electrode Arrangements

Described below are embodiments of various treatment devices and, moreparticularly, electrode arrangements that may be used for applyingenergy to the Eustachian tube or surrounding tissues. These electrodesmay, for example, deliver RF energy to preferentially shape the tissueto provide improved Eustachian tube function. In some embodiments, oneor more electrodes may be used alone or in combination with a tissueshaping device or mold. In other embodiments, one or more electrodes maybe integrally formed with a tissue shaping device or mold, so that theelectrodes themselves create the shape for the tissue. In someembodiments, the energy delivery devices may utilize alternatingcurrent. In some embodiments, the energy delivery devices may utilizedirect current. In certain such embodiments, the energy delivery devicemay include a configuration utilizing a grounding pad.

In some embodiments, the term “electrode” refers to any conductive orsemi-conductive element that may be used to treat the tissue. Thisincludes, but is not limited to metallic plates, needles, and variousintermediate shapes such as dimpled plates, rods, domed plates, etc.Electrodes may also be configured to provide tissue deformation inaddition to energy delivery. Unless specified otherwise, electrodesdescribed can be monopolar (e.g., used in conjunction with a groundingpad) or bipolar (e.g., alternate polarities within the electrode body,used in conjunction with other tissue-applied electrodes).

In some embodiments, “mold”, “tissue shaper”, “reshaping element” andthe like refer to any electrode or non-electrode surface or structureused to shape, configure or deflect tissue during treatment.

In some embodiments, “counter-traction” refers to applying a forceopposite the electrode's primary force on the tissue to increasestability, adjustability, or for creating a specific shape.

In some embodiments, monopolar needles may be used to deliver energy.The needle electrodes 240 may be placed internally, penetrating throughtissue to underlying tissue, and a remote grounding pad 242 or elementmay be placed externally. In some embodiments, monopolar needles may beused in conjunction with one or more molding elements which may bedisposed on or around the needles. In some embodiments, monopolartransdermal needles may be used to deliver energy. In other embodiments(not shown), the needles may be placed external to the patient, andpenetrate through to tissue to be treated. Needle configurations mayadvantageously target the particular tissue to be treated specifically.The monopolar transdermal needles may be used in conjunction with aninternal molding device (not shown).

In some embodiments, bipolar needles may be used to deliver energy totissue to be treated. The needles may be placed internally, with aninsulating spacer between them and may penetrate through tissue tounderlying tissue to be treated. In some embodiments, the bipolarneedles may be used in combination with one or more internal moldingelements. The one or more molding elements may be placed on or near theneedles. In some embodiments, bipolar needles may be used to deliverenergy. In other embodiments, the needles may be placed externally andpenetrate through to tissue to be treated. Needle configurations mayadvantageously target particular tissue. The bipolar needles may beutilized in conjunction with an internal molding element.

As shown in FIG. 4A, in some embodiments, an array of electrodesincluding one, two, or many pairs of bipolar needles 252 are located ona treatment element configured to be placed into contact with tissue. Aninsulator 254 may be disposed between the bipolar needles 252. Aninsulator may also be utilized on part of the needle's length to allowenergy to be delivered only to certain tissue structures, such ascartilage or muscle. The electrodes may be placed internally orexternally. The insulator 254 may also function as a mold or moldingelement. In some embodiments, the array of electrodes is used inconjunction with a separate tissue reshaping element.

FIG. 4B illustrates another embodiment of a treatment element includingone or more pairs of bipolar electrodes 260. As opposed to FIG. 4A,where the pairs of electrodes are arranged side-by-side, the embodimentof FIG. 4B arranges the pairs of electrodes along the length of thetreatment element. The electrodes of FIG. 4B are also non-penetrating,in contrast to the needles of FIG. 4A. The electrodes 260 may, forexample, be placed against the skin (externally) against internal tissue(e.g., mucosa) to deliver energy to target tissue such as cartilage ormuscle.

In some embodiments of treatment devices including an array or multiplepairs of electrodes, each pair of electrodes (bipolar) or each electrode(monopolar) may have a separate, controlled electrical channel to allowfor different regions of the treatment element to be activatedseparately. For example, the needles or needle pairs of FIG. 4A may beindividually controlled to produce an optimal treatment effect. Foranother example, separate electrodes may be individually controlled toproduce an optimal treatment effect. Other examples are alsocontemplated. The channels may include separate or integrated feedback.This may advantageously allow for more accurate temperature control andmore precise targeting of tissue. Separate control may also allow energyto be focused and/or intensified on a desired region of the treatmentelement in cases where the anatomy of tissue and/or structures does notallow the entire electrode region of the treatment element to engage thetissue. In such embodiments, the tissue that is in contact with thetreatment element may receive sufficient energy to treat the tissue.

Examples of Treatment Devices Including Electrodes

FIGS. 5A and 5B illustrate embodiments of treatment devicesincorporating treatment elements such as electrodes. The instrumentdesigns described in these embodiments may be used in a device such asthe device 30, described above, and in the system of FIG. 3. In someembodiments, the devices provide tissue reshaping or molding in additionto energy delivery. Applying energy to the Eustachian tube orsurrounding tissues may require properly positioning the electrode(s) atparticular tissue, deflecting or deforming the tissue into a morefunctional shape, and delivering or applying energy consistently priorto device removal. Embodiments described herein may advantageouslyprovide adjustability, visualization of effect, ease of use, ease ofmanufacturability and component cost. Molding and reshaping of theEustachian tube or surrounding tissues may allow for non-surgicalEustachian tube improvement without the use of implants.

FIG. 5A depicts a device 300 including a single monopolar electrode 301located at the end of a shaft 302. The shaft is attached to a handle 303This embodiment may advantageously be simple to manufacture and mayminimize current flow through, for example, the skin. In someembodiments, a monopolar electrode may be placed externally and may beconnected to a molding element within the patient as well as a remotegrounding pad. This embodiment may also advantageously be simple tomanufacture, may minimize mucosal current flow, and may also be simpleto position. In some embodiments, electrodes placed internally may beshaped to function as a mold or may include an additional structure thatmay function as a mold.

FIG. 5B depicts another device 304 including a single monopolarelectrode 305. The electrode 305 is located at the distal end of a shaft306, which is attached to a handle 307. The handle includes a powerbutton 308 that may be used to activate and deactivate the electrode. Asstated above, the device 304 may either include a generator or beconnected to a remote generator. The electrode 305 may be provided on anenlarged, distal end of the shaft 306, and in the embodiment illustratedhas a convex shape configured to press against and create a concavity intissue.

FIG. 6 depicts a device 390 including pairs of bipolar electrodes 392located at the distal end of a shaft 394. The electrodes may be similarto the electrodes described with respect to the electrode configurationof FIG. 4B in that they are non-penetrating. The shaft 394 is connectedto a handle 398 which includes a button configured to activate anddeactivate the electrodes. As stated above, the device 380 may eitherinclude a generator or be connected to a remote generator.

FIG. 7A depicts the treatment element 502 of a treatment device (e.g.,device 30). The treatment element 502 of the device includes a monopolarelectrode 504. A cross-section of the treatment element 502 is shown inFIG. 7B. It includes an asymmetrical shape and has a convex surfacewhere the electrode is positioned configured to conform to tissue. Thetreatment element 502 further includes a light 506 configured toilluminate the treatment area. For example an LED or a visible laser maybe used. The visible laser may experience less diffusion in the tissue.

Furthermore, the light 506 can be situated such that light can betransmitted through the tissue (including the skin) and can bevisualized externally by the user (e.g., during a procedure). The usercan then use the light to properly position the device in the desiredlocation.

FIG. 8A depicts the treatment element 512 of a treatment device (e.g.,device 30). The treatment element 512 of the device includes twomonopolar electrodes 514, 516 provided side-by-side on a convex surfaceof the treatment element. The cross section of the treatment element 512may be configured to conform to the shape of particular tissue. Eachelectrode may be activated separately, simultaneously, and/or in analternating fashion. The treatment element 512 also includes two lights518, 520 (e.g., LEDs, lasers) configured to illuminate the treatmentarea. One or both of the lights 518, 520 can also be situated such thatlight can be transmitted through the skin and can be visualizedexternally by the user. The user can then use the light to properlyposition the device in the desired location.

FIG. 9A depicts a treatment element 522 of a treatment device (e.g.,device 30). The tip 522 of the device includes a monopolar electrode524. The tip 522 includes a symmetrical cross-section as shown in FIG.9B. The tip 522 includes a light 526 (e.g., LED) configured toilluminate the treatment area. The light 526 can also be situated suchthat light can be transmitted through the skin and can be visualizedexternally by the user. The user can use the light to properly positionthe device in the desired location.

FIGS. 10A-G depict a treatment device 530 similar to the embodiments ofFIGS. 5A, and 5B. FIGS. 10A and 10F provide perspective views of thedevice 530. The device 530 includes a treatment element 532 at itsdistal tip 534. The treatment element 532 includes an electrode 535. Thebody of the treatment element 532, itself, may include an insulatingmaterial. The treatment element 532 may be provided on an enlargeddistal tip 534 of an elongate shaft 536, and as in the embodimentillustrated, may have a convex shape configured to press against andcreate a concavity in tissue. The distal tip 534 is located at thedistal end of shaft 536. The shaft is attached at its proximal end to ahandle 538. The handle 538 includes an input control such as a powerbutton 540 on its front side that may be used to activate and deactivatethe electrode. The power button 540 may be positioned in a recess of thehandle to allow for finger stability when activating and deactivatingthe electrode. In other embodiments, the input control is in the form ofa switch or dial. Other configurations are also possible as describedabove.

The device 530 includes a flexible wire or cable 542 electricallyconnected to an adaptor 544. The adaptor 544 can be used to connect thedevice 530 to a remote generator (not shown). The adaptor 544 may allowtransmission of treatment energy between a remote generator and thedevice 530. The adaptor may also allow transmission of any sensorsignals between the device 530 and a generator or control unit. Thedevice 530 may either include an integrated generator or be connected toa remote generator. The treatment device 530 may be provided in a systemor kit also including the remote generator. The system or kit (with orwithout the remote generator) may also include a grounding device and/ora cooling device as described above and further below. In someembodiments, the kit may incude a positioning element configured to helpa user locate the optimal treatment area.

FIGS. 10B and 10C depict front and back views of the device. As shown inFIGS. 10B and 10C, the handle 538 of the device generally as a roundedelongate shape. Other shapes are also possible. For example the device530 may have a square shaped cross section. In some embodiments, acircumference (or width or cross-sectional area) of the handle 538 mayincrease distally along the length of the handle 538.

FIGS. 10D and 10E depict side views of the device. As shown in FIGS. 10Dand 10E, the handle 538 of the device 530 may include an indentation orrecess around the middle of the handle 538. This may allow for enhancedgrip and control when a user is holding the device. The indentation orrecess may be near the input control or power button 540 to allow a userto easily activate and deactivate the device while holding it in acomfortable position.

In some embodiments, the shaft has a width or diameter of about 0.125inches to about 0.25 inches. In some embodiments, the shaft is about 1.5inches to about 4 inches long. In some embodiments, the shaft includes apolymer such as polycarbonate or PEEK. In other embodiments, the shaftincludes stainless steel or other metals. The metals may be coated withan external and/or internal insulating coating (e.g., polyester,polyolefin, etc.). The handle may include the same material as theshaft, in some embodiments. In some embodiments, the shaft is rigid.This may allow a user of the device increased control over thedeformation of nasal tissue. In some embodiments, the shaft comprisessome amount of flexibility. This flexibility may allow a user adjust anangle of the distal tip by bending the distal end of the shaft.

FIG. 10G depicts a larger view of the distal tip 534 of the device 530.As shown best in FIG. 10G, the treatment element 532 includes agenerally elongate shape. The front of the treatment element 532includes a shallow, curved surface, providing a convex shape configuredto deform the nasal tissue and create a concavity therein. In someembodiments, the front of the treatment element includes a concaveshape. The shape of the front surface of the treatment element may beselected to conform to the nasal tissue. The back of the treatmentelement 532 also includes a shallow curved surface. As best seen inFIGS. 10D and 10E, the back surface varies in width along the length ofthe back surface of the treatment element 532. The back surface widens,moving distally along the tip until it is nearly in line with theproximal end of the electrode plate 535. The back surface then narrowstowards the distal tip of the treatment element 532. This shape maymaximize visualization of the area to be treated, while, at the sametime, providing sufficient rigidity for treatment. Other shapes are alsopossible. For example, the treatment element may include a generallyspherical or cylindrical shape. In some embodiments, the treatmentelement includes an angular shape (e.g., triangular, conical) which mayallow for close conformation to the tissue structures. The treatmentelement 532 includes a monopolar electrode plate 535. The monopolarelectrode plate 535 can be in the shape of a rectangle having a curvedor convex tissue-facing surface. Other shapes are also possible (e.g.,square, circular, ovular, etc.). The electrode 535 may protrude slightlyfrom the treatment element 535. This may allow the electrode to itselfprovide a convex shape configured to create a concavity in tissue to betreated.

In some embodiments, the treatment element has a width or diameter ofabout 0.25 inches to about 0.45 inches. In some embodiments, thetreatment element is about 0.4 inches to about 0.5 inches long. Thetreatment element can, in some embodiments, include a ceramic material(e.g., zirconium, alumina, silicon glass). Such ceramics mayadvantageously possess high dielectric strength and high temperatureresistance. In some embodiments, the treatment element includespolyimides or polyamides which may advantageously possess gooddielectric strength and elasticity and be easy to manufacture. In someembodiments, the treatment element includes thermoplastic polymers.Thermoplastic polymers may advantageously provide good dielectricstrength and high elasticity. In some embodiments, the treatment elementincludes thermoset polymers, which may advantageously provide gooddielectric strength and good elasticity. In some embodiments, thetreatment element includes glass or ceramic infused polymers. Suchpolymers may advantageously provide good strength, good elasticity, andgood dielectric strength.

In some embodiments, the electrode has a width of about 0.15 inches toabout 0.25 inches. In some embodiments, the electrode is about 0.2inches to about 0.5 inches long. In some embodiments, the treatmentelement includes steel (e.g., stainless, carbon, alloy). Steel mayadvantageously provide high strength while being low in cost andminimally reactive. In some embodiments, the electrodes or energydelivery elements described herein include materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein include anodizedaluminum. Anodized aluminum may advantageously be highly stiff and lowin cost. In some embodiments, the electrodes or energy delivery elementsdescribed herein include titanium which may advantageously possess ahigh strength to weight ratio and be highly biocompatible. In someembodiments, the electrodes or energy delivery elements described hereininclude nickel titanium alloys. These alloys may advantageously providehigh elasticity and be biocompatible. Other similar materials are alsopossible.

As shown in the embodiment of FIG. 10G, the treatment element 532further includes a pin-shaped structure including a thermocouple 533within an insulating bushing extending through a middle portion of theplate 535. In some embodiments, different heat sensors (e.g.,thermistors) may be used. In some embodiments, the thermocouple 533 isconfigured to measure a temperature of the surface or subsurface oftissue to be treated or tissue near the tissue to be treated. Apin-shape having a sharp point may allow the structure to penetrate thetissue to obtain temperature readings from below the surface. Thethermocouple can also be configured to measure a temperature of thetreatment element 532 itself. The temperature measurements taken by thethermocouple can be routed as feedback signals to a control unit (e.g.,the control system 42 described with respect to FIG. 3) and the controlunit can use the temperature measurements to adjust the intensity ofenergy being delivered through the electrode. In some embodiments,thermocouples or other sensing devices may be used to measure multipletissue and device parameters. For example, multiple thermocouples orthermistors may be used to measure a temperature at different locationsalong the treatment element. In some embodiments, one of the sensors maybe configured to penetrate deeper into the tissue to take a measurementof a more interior section of tissue. For example, a device may havemultiple sensors configured to measure a temperature at the Eustachiantube, surrounding tissue, and/or the treatment element itself. Asdescribed above, in some embodiments, the sensors described herein areconfigured to take a measurement of a different parameter. For example,tissue impedance can be measured. These measurements can be used toadjust the intensity and/or duration of energy being delivered throughthe treatment element. This type of feedback may be useful from both anefficacy and a safety perspective.

As shown in FIG. 10G, in some embodiments the thermocouple is within apin shaped protrusion on the surface of the electrode 535. In otherembodiments, the thermocouple can simply be on the surface of theelectrode. In other embodiments, the thermocouple can protrude from thesurface of the electrode in a rounded fashion. Rounded structures may bepressed into the tissue to obtain subsurface temperature readings. Otherconfigurations and locations for the thermocouple are also possible. Theuse of thermocouples or temperature sensors may be applied not only tothe embodiment of FIG. 10G, but also to any of the other embodimentsdescribed herein.

FIGS. 11A-G depict a treatment device 550 similar to the embodiment ofFIG. 4A. FIGS. 11A and 11F are perspective views of the device 550 andshow the device 550 including a treatment element 552 at the distal tip556 of the device 550. The treatment element 552 may be provided on anenlarged distal tip 556 of an elongate shaft 558, and as in theembodiment illustrated, may have a convex shape configured to pressagainst and create a concavity in tissue. The distal tip 556 is locatedat a distal end of shaft 558. The shaft is attached at its proximal endto a handle 560. The handle 560 includes an input control, such as apower button 562, on its front side that may be used to activate anddeactivate the electrode. The power button may be positioned in a recessof the handle to allow for finger stability when activating anddeactivating the electrode. In other embodiments, the input control isin the form of a switch or dial. Other configurations are also possibleas described above. The device 550 may either include a generator or beconnected to a remote generator. The device 550 may include a flexiblewire or cable 564 that connects to an adaptor 566 that is configured tobe plugged into a remote generator (not shown). The adaptor 566 mayallow transmission of treatment energy between a remote generator andthe device 550. The adaptor 566 may also allow transmission of anysensor signals between the device 550 and a generator or control unit.The treatment device 550 may be provided in a system or kit alsoincluding the remote generator. The system or kit (with or without theremote generator) may also include a grounding device and/or a coolingdevice as described above and further below. In some embodiments, thekit includes a positioning element configured to help a user locate theoptimal treatment area.

In some embodiments, the shaft has a width or diameter or about 0.235inches to about 0.25 inches. In some embodiments, the shaft is about 1.5inches to about 4 inches long. In some embodiments, the shaft and/orhandle includes a polymer such as polycarbonate or PEEK. In otherembodiments, the shaft includes stainless steel or other metals. Themetals may be coated with an external and/or internal insulating coating(e.g., polyester, polyolefin, etc.). The handle may include the samematerial as the shaft, in some embodiments. In some embodiments, theshaft is rigid. This may allow a user of the device increased controlover the deformation of nasal tissue. In some embodiments, the shaftincludes some amount of flexibility. This flexibility may allow a useradjust an angle of the distal tip by bending the distal end of theshaft.

FIGS. 11B and 11C depict side views of the device. As shown in FIGS. 11Band 11C, the handle 560 of the device 550 may include an indentation orrecess around the middle of the handle 560. This may allow for enhancedgrip and control when a user is holding the device. The indentation orrecess may be near the input control or power button 562 to allow a userto easily activate and deactivate the device while holding it in acomfortable position.

FIGS. 11D and 11E depict front and back views of the device. As shown inFIGS. 11D and 11E, the handle 560 of the device generally includes arounded elongate shape. Other shapes are also possible. For example thedevice 550 may have a square shaped cross section. In some embodiments,a circumference (or width or cross-sectional area) of the handle 560 mayincrease distally along the length of the handle 560.

FIG. 11G depicts a larger view of the distal tip 556 of the device 550.As shown best in FIG. 11G, the treatment element 552 includes agenerally elongate shape. The front of the treatment element 552includes a shallow curved surface, providing a convex shape configuredto deform the tissue and create a concavity therein. In someembodiments, the front of the treatment element includes a concaveshape. The shape of the front surface of the treatment element may beselected to conform to tissue. The back surface of the treatment element552 includes a shallow curved surface along most of its length. As bestseen in FIGS. 11B and 11C, the back surface narrows distally along thelength of the element 552 from approximately the distal end of theneedle electrodes to the distal tip of the treatment element 552. Thisshape may maximize visualization of the area to be treated, while, atthe same time, providing sufficient rigidity for treatment. Other shapesare also possible. For example, the treatment element may include agenerally spherical or cylindrical shape. In some embodiments, thetreatment element includes an angular shape (e.g., triangular, conical)which may allow for close conformation to the tissue structures. Thetreatment element 552 includes a monopolar or bipolar needle arrayincluding multiple needles 554. In some embodiments, the needles 554 areenergized in between select needles to deliver bipolar energy. In otherembodiments, the energy is delivered between the needles 554 and aremote grounding pad (not shown). In some embodiments, the electrodeneedle pairs are arranged horizontally across the treatment element 552.In some embodiments, the electrode needle pairs are arranged verticallyacross the treatment element 552, or along the direction of the shaft558 and handle 560. Other configurations are also possible. For example,the needle pairs may be arranged diagonally across the treatment element552. The treatment element 552 may be placed either internally or thetreatment element 552 may be placed externally. The distal tip 556 ofthe device 550 may also function as a mold or molding element. In amonopolar embodiment, the energy may be selectively delivered betweencertain sets of needles, all needles, or even individual needles tooptimize the treatment effect.

The treatment element 552 of the device 550 further includes apin-shaped structure including a thermocouple 555 within an insulatingbushing extending through a middle portion of the front surface of thetreatment element 552. In some embodiments, different heat sensors(e.g., thermistors) may be used. As described above, in someembodiments, the thermocouple 555 is configured to measure a temperatureof the surface or subsurface of tissue to be treated or tissue near thetissue to be treated. A pin-shape having a sharp point may allow thestructure to penetrate the tissue to obtain temperature readings frombelow the surface. The thermocouple can also be configured to measure atemperature of the treatment element 552 itself. The temperaturemeasurements taken by the thermocouple can be routed as feedback signalsto a control unit (e.g., the control system 42 described with respect toFIG. 3) and the control unit can use the temperature measurements toadjust the intensity of energy being delivered through the electrode. Insome embodiments, thermocouples or other sensing devices may be used tomeasure multiple tissue and device parameters. For example, multiplethermocouples or thermistors may be used to measure a temperature atdifferent locations along the treatment element. In some embodiments,one of the sensors may be configured to penetrate deeper into the tissueto take a measurement of a more interior section of tissue. For example,a device may have multiple sensors configured to measure a temperatureat the mucosa, the cartilage, and/or the treatment element itself. Asdescribed above, in some embodiments, the sensors described herein areconfigured to take a measurement of a different parameter. For example,tissue impedance can be measured. These measurements can be used toadjust the intensity and/or duration of energy being delivered throughthe treatment element. This type of feedback may be useful from both anefficacy and a safety perspective.

In some embodiments, the treatment element has a width or diameter ofabout 0.25 inches to about 0.45 inches. In some embodiments, thetreatment element is about 0.4 inches to about 0.5 inches long. Thetreatment element can, in some embodiments, include a ceramic material(e.g., zirconium, alumina, silicon glass). Such ceramics mayadvantageously possess high dielectric strength and high temperatureresistance. In some embodiments, the treatment element includespolyimides or polyamides which may advantageously possess gooddielectric strength and elasticity and be easy to manufacture. In someembodiments, the treatment element includes thermoplastic polymers.Thermoplastic polymers may advantageously provide good dielectricstrength and high elasticity. In some embodiments, the treatment elementincludes thermoset polymers, which may advantageously provide gooddielectric strength and good elasticity. In some embodiments, thetreatment element includes glass or ceramic infused polymers. Suchpolymers may advantageously provide good strength, good elasticity, andgood dielectric strength.

In some embodiments, the electrodes have a width or diameter of about0.15 inches to about 0.25 inches. In some embodiments, the electrode isabout 0.2 inches to about 0.5 inches long. In some embodiments, thetreatment element includes steel (e.g., stainless, carbon, alloy). Steelmay advantageously provide high strength while being low in cost andminimally reactive. In some embodiments, the electrodes or energydelivery elements described herein include materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein include anodizedaluminum. Anodized aluminum may advantageously be highly stiff and lowin cost. In some embodiments, the electrodes or energy delivery elementsdescribed herein include titanium which may advantageously possess ahigh strength to weight ratio and be highly biocompatible. In someembodiments, the electrodes or energy delivery elements described hereininclude nickel titanium alloys. These alloys may advantageously providehigh elasticity and be biocompatible. Other similar materials are alsopossible.

Energy applied to the tissue to be treated using any combination of theembodiments described in this application may be controlled by a varietyof methods. In some embodiments, temperature or a combination oftemperature and time may be used to control the amount of energy appliedto the tissue. Tissue is particularly sensitive to temperature; soproviding just enough energy to reach the target tissue may provide aspecific tissue effect while minimizing damage resulting from energycausing excessive temperature readings. For example, a maximumtemperature may be used to control the energy. In some embodiments, timeat a specified maximum temperature may be used to control the energy. Insome embodiments, thermocouples, such as those described above, areprovided to monitor the temperature at the electrode and providefeedback to a control unit (e.g., control system 42 described withrespect to FIG. 3). In some embodiments, tissue impedance may be used tocontrol the energy. Impedance of tissue changes as it is affected byenergy delivery. By determining the impedance reached when a tissueeffect has been achieved, a maximum tissue impedance can be used tocontrol energy applied.

In the embodiments described herein, energy may be produced andcontrolled via a generator that is either integrated into the electrodehandpiece or as part of a separate assembly that delivers energy orcontrol signals to the handpiece via a cable or other connection. Insome embodiments, the generator is an RF energy source configured tocommunicate RF energy to the treatment element. For example, thegenerator may include a 460 KHz sinusoid wave generator. In someembodiments, the generator is configured to run between about 1 and 100watts. In some embodiments, the generator is configured to run betweenabout 5 and about 75 watts. In some embodiments, the generator isconfigured to run between about 10 and 50 watts.

In some embodiments, the energy delivery element includes a monopolarelectrode (e.g., electrode 535 of FIG. 10G). Monopolar electrodes areused in conjunction with a grounding pad. The grounding pad may be arectangular, flat, metal pad. Other shapes are also possible. Thegrounding pad may include wires configured to electrically connect thegrounding pad to an energy source (e.g., an RF energy source).

In some embodiments, the energy delivery element such as the electrodesdescribed above can be flat. Other shapes are also possible. Forexample, the energy delivery element can be curved or include a complexshape. For example, a curved shape may be used to place pressure ordeform the tissue to be treated. The energy delivery element may includeneedles or microneedles. The needles or microneedles may be partially orfully insulated. Such needles or microneedles may be configured todeliver energy or heat to specific tissues while avoiding tissues thatshould not receive energy delivery.

In some embodiments, the electrodes or energy delivery elementsdescribed herein include steel (e.g., stainless, carbon, alloy). Steelmay advantageously provide high strength while being low in cost andminimally reactive. In some embodiments, the electrodes or energydelivery elements described herein include materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein include anodizedaluminum. Anodized aluminum may advantageously be highly stiff and lowin cost. In some embodiments, the electrodes or energy delivery elementsdescribed herein include titanium which may advantageously possess ahigh strength to weight ratio and be highly biocompatible. In someembodiments, the electrodes or energy delivery elements described hereininclude nickel titanium alloys. These alloys may advantageously providehigh elasticity and be biocompatible. Other similar materials are alsopossible.

In some embodiments, the treatment elements (e.g., non-electrode portionof treatment element) of the devices described herein include aninsulating material such as a ceramic material (e.g., zirconium,alumina, silicon glass). In some embodiments, the treatment elementsinclude an insulating material interposed between multiple electrodes orelectrode section. These insulating sections may provide an inertportion of the treatment element that does not delivery energy to thetissue. Such ceramics may advantageously possess high dielectricstrength and high temperature resistance. In some embodiments, theinsulators described herein include polyimides or polyamides which mayadvantageously possess good dielectric strength and elasticity and beeasy to manufacture. In some embodiments, the insulators describedherein include thermoplastic polymers. Thermoplastic polymers mayadvantageously provide good dielectric strength and high elasticity. Insome embodiments, the insulators described herein include thermosetpolymers, which may advantageously provide good dielectric strength andgood elasticity. In some embodiments, the insulators described hereininclude glass or ceramic infused polymers. Such polymers mayadvantageously provide good strength, good elasticity, and gooddielectric strength.

In some embodiments, the handle and/or shaft of the devices include thesame materials as those described with respect to the insulators. Insome embodiments, the handle and/or shaft of the device includes ametal, such as stainless steel. In other embodiments, the handle and/orshaft of the device includes a polymer, such as polycarbonate. Othermetals and polymers are also contemplated.

In some embodiments, the device may be used in conjunction with apositioning element that can be used to aid in positioning of thedevice. The positioning element may be integrated into the device itselfor can be separate. The positioning element may be used to determine theoptimal placement of the device to achieve maximal increase in efficacy.

In some embodiments, a positioning element includes a shaft includingmeasurement marks indicating depth. For example, a physician may insertthis element into an airway of the patient to find an appropriatetreatment depth of treatment. The positioning element may include marksaround the base of the shaft and/or along the length of the shaftindicating rotation and depth, respectively. The positioning element mayalso include marks indicating angle of insertion. The physician may thenuse the measurement marks to guide insertion of the treatment element toa particular spot.

It will be appreciated that any combination of electrode configurations,molds, handles, connection between handles, and the like may be used totreat the Eustachian tube and/or surrounding tissues.

Cooling Systems

Embodiments of devices configured to heat specific tissue whilemaintaining lower temperatures in other adjacent tissue are provided.These devices may be incorporated into any of the treatment apparatusesand methods described herein. The Eustachian tube and surrounding tissueis an example of tissue that may benefit from being maintained atdifferent temperatures. Other examples include the skin, which includesthe epidermis, dermis, and subcutaneous fat, the tonsils, which includemucosa, glandular tissue, and vessels. Treatment of other tissuecomplexes is also possible. For example, in some embodiments, theinternal structures of a patient's head may be heated while maintaininga lower temperature in mucosal lining of the nasopharynx and/or skin. Inother embodiments, mucosa, skin, or other tissue may be heated, whilemaintaining lower temperatures elsewhere. Limiting unwanted heating ofnon-target tissues may allow trauma and pain to be reduced, may reducescarring, may preserve tissue function, and may also decrease healingtime. Combinations of heat transfer and/or heat isolation may allowdirected treatment of specific tissue such as cartilage or muscle, whileexcluding another tissue, such as mucosa, without surgical dissection.

Generally, when using a device 570 with an electrode 572 (e.g.,monopolar RF electrode) to heat tissue, the electrode 572 must be incontact with tissue. FIG. 12A shows a cross-section of tissue. Thecross-section shows a first layer or depth 702, a second layer or depth704, and a third layer or depth 704. When the electrode 572 isactivated, both the first and second layers or depths 702, 704 areheated by the current flowing from the electrode to the return (e.g.,ground pad), as shown in FIG. 12B. The tissue closest to the electrode572 receives the highest current density, and thus, the highest heat. Asurface cooling mechanism may allow the temperature of the electrodesurface to be reduced. Such a cooling mechanism may maintain a lowertemperature at the first layer or depth 702 even though current flowwill continue to heat the second layer or depth 704.

FIG. 13A depicts a device 580 configured to treat the Eustachian tubeand surrounding tissue using an electrode while maintaining a reducedtemperature at a first layer or depth. The device includes a treatmentelement 582 including an electrode 584 at the distal tip of the device580. The treatment element 582 is attached to a distal end of a shaft586, which is attached to the distal end of a handle 588. Input andoutput coolant lines 590, 592 are attached to a pump and reservoir 594and extend into the handle 588, through the distal end of the treatmentelement 582 to the electrode 584 and return back through the shaft 586and handle 588 to the pump and reservoir 594. The coolant may beremotely cooled in the reservoir and may include a fluid or gas. Thecoolant flowing through the electrode 584 may allow the treatmentelement 582 to be maintained at a reduced temperature while stillallowing current flow to a deeper layers or areas of tissue. Examples ofcoolant include air, saline, water, refrigerants, and the like. Watermay advantageously provide moderate heat capacity and be non-reactive.Refrigerants may advantageously be able to transfer significant amountsof heat through phase change. The coolant may flow through internal orexternal cavities of the electrode or wand tip. For example, FIG. 13Bdepicts an embodiment of a device 600 including a treatment element 602with an electrode 604 at the distal tip of the device 600. The treatmentelement 602 is attached to the distal end of a shaft 606 which isattached to the distal end of a handle 608. The handle may be attachedto a cable includes a lumen or channel 611 through which gas or fluidmay flow. The lumen 611 may diverge, near the treatment element 602,into separate external channels flowing over the electrode 604. Thelumen 611 and channels 610 or cavities may be attached to a fan or fluidpump 612. In some embodiments, the fan or fluid pump may remotely coolthe gas or fluid.

FIG. 14 depicts another embodiment of a device 620 configured to treatthe Eustachian tube or surrounding tissue using an electrode 624 whilemaintaining a reduced temperature at the a particular depth or layer.The device includes a treatment element 622 including an electrode 624at its distal end. The treatment element 622 is connected to the distalend of a shaft 626 which is connected to the distal end of a handle 628.The device 620 includes a heat pipe 630 attached to the electrode 624 ortreatment element 622. The heat pipe 630 is configured to transfer heatto a remote heat sink 632. As shown in FIG. 14, the heat sink 632 may beplaced in the handle of the device. In some embodiments, the heat sinkmay be placed remotely. The heat pipe 630 may include a sealed tube(e.g., a copper tube) filled with a material that evaporates at a giventemperature. When one end of the heat pipe 630 is heated, the fluid mayevaporate and flow to the opposite end where it may condense andsubsequently transfer heat to the heat sink 632. Using a material suchas copper for the heat pipe 630 and/or heat sink 632 may advantageouslyprovide high heat and electrical conductivity.

Embodiments may employ specific differential cooling mechanisms tomaintain different and particular temperatures in adjacent tissues. Theembodiments may be configured to provide more general mechanismsconfigured to maintain different temperatures in adjacent tissues. Forexample, in some embodiments, a cooling mechanism may be placed externalto patient (e.g., against the patient's skin) to provide an amount ofcooling.

Cooling occurring before, during, or after treatment may effect reducedtemperature of tissue. In some embodiments, attaching passive fins orother structures to the electrode or wand tip may allow for heatdissipation to the surrounding air. In some embodiments, the device maybe configured to spray a cool material such as liquid nitrogen before,during, or after treatment. Using a material such as copper for thepassive fins or other structure may advantageously provide high heat andelectrical conductivity. In some embodiments, using metals with a highheat capacity in the device (e.g., in the energy delivery element, thereshaping element, or both) may advantageously provide the ability toresist temperature change during energy delivery. In some embodiments,pre-cooling the electrode (e.g., by refrigeration, submersion, sprayingwith a cool substance like liquid nitrogen, etc.) may maintain a reducedtemperature at a first layer or depth. Any combination of the coolingmethods described herein may be used in conjunction with any of theenergy delivery methods described herein (e.g., bipolar RF electrodes,arrays needles, plates, etc.).

FIG. 15 illustrates an example embodiment of a device 800 including atreatment element 802 including electrode needles 804 at its distal tip.The device 800 may be used in conjunction with a separate cooling device810 which may include channels 812 or cavities to circulate air orfluid. The independent cooling device 810 may, in other embodiments,employ a different cooling mechanism.

In embodiments using laser energy to heat cartilage, it is possible touse a combination of two or more lasers whose beams converge at alocation within the target tissue. This convergence may cause more heatat that junction as compared to locations where only a single beam isacting. The junction may be controlled manually or via computer control.Specific treatment may be provided.

In some embodiments, insulating material may be used to protectnon-target tissue during energy delivery. For example, an electrodeneedle may be preferentially insulated on a portion of the needle thatis in contact with non-target tissue. For another example, flatelectrode blades may be insulated on a portion of the blade that is incontact with non-target tissue. Other configurations for heat isolationare also possible.

Any of the cooling mechanisms or combinations of the cooling mechanismsdescribed herein may be used in conjunction with any of the devices orcombinations of devices described herein, or the like.

Additional Examples of Methods of Treatment

Embodiments of methods for treating a Eustachian tube and surroundingtissue are now described. In one embodiment, a method of treating aEustachian tube and surrounding tissue includes the steps of insertingan energy-delivery or cryotherapy device into a nasal passageway, andapplying energy or cryotherapy to a targeted region or tissue of thenasopharynx. For example, in some embodiments, the method may includedelivering energy or cryotherapy to a section of the nasopharynx in thearea of the Eustachian tube. In alternative embodiments, the method mayinvolve delivering energy to the tissue of the ear canal near theEustachian tube.

In some embodiments, a method includes reshaping tissue. For example,such a method may include heating or delivering another energy form to asection of the Eustachian tube or surrounding tissue (e.g., cartilage)to be reshaped, applying a mechanical reshaping force to the tissue, andthen removing the heat or other energy. In various alternativeembodiments, the step of applying the mechanical reshaping force mayoccur before, during or after the step of applying heat or other energy.In one embodiment, for example, an energy delivery member having aconvex treatment surface may be applied to a target tissue, and theconvex treatment surface may be pushed into the tissue with sufficientforce to give the tissue a concave shape. Energy may be applied to thetissue, while the force is applied, so that after the treatment deviceis removed, the tissue retains at least some of the concave shape. Othershape combinations are possible in alternative embodiments, and thisexample is provided for exemplary purposes only.

Referring to FIGS. 16A-16C, one embodiment of a method for treating aEustachian tube is illustrated. As shown in FIG. 16A, the method mayfirst involve advancing a Eustachian tube treatment device 1000 to atreatment area (e.g., by advancing the treatment device 1000 through anasal passage and into the Eustachian tube). The treatment device 1000may include a shaft 1002, a treatment portion 1004 (or “treatmentelement”) having a tissue treatment surface 1008, and multiple energydelivery members 1006 disposed along the treatment surface 1008. In thisembodiment, the energy delivery members 1006 are bipolar radiofrequencyelectrode needles, disposed in an array along the treatment surface1008. In alternative embodiments, however, any of the energy delivery orremoval members described in this disclosure may be used. In FIG. 16A,the treatment device 1000 is illustrated from a top/perspective view.

Referring now to FIG. 16B, the method may next involve contacting thetissue treatment surface 1008 with tissue to be treated and applyingforce with the treatment surface 1008 against the tissue, to temporarilydeform the tissue. For example, as described herein, the tissuetreatment surface 1008 may have a convex shape in some embodiments, sothat when it is pressed against tissue of or near the Eustachian tube,that tissue takes on a concave shape. In FIG. 16B, the treatment device1000 is shown in a side view, illustrating that the shaft 1002 may havea bend 1003, or alternatively multiple bends or curves. The bend 1003may allow the treatment device 1000 to be more easily advanced into theEustachian tube, and it may also make it easier to apply force againstthe tissue to be treated.

In some embodiments, the energy delivery members 1006 may be designed topierce through mucosal tissue to apply energy to one or more deepertissues. In the example shown, the energy delivery members 1006 areadvanced into the tensor tympani muscle. Alternatively, other musclesand/or other tissues below the surface of the mucosa may be treated.

Referring to FIG. 16C, in one embodiment, the method next involvesapplying energy to the tissue being treated, using the energy deliverymembers 1006. In various embodiments, the energy may be deliveredbefore, during and/or after application of force against the tissue withthe tissue treatment surface 1004. In any such embodiment, the treatedtissue may retain at least a partially reshaped configuration after thetreatment device 1000 is removed from the patient.

In some embodiments, the tissue treatment device 1000 may be used oncein a given Eustachian tube to treat one portion of target tissue. Forexample, in one embodiment, the treatment device 1000 may be used totreat an upper (cephalic) portion of tissue, in an effort to help liftthe tissue of the Eustachian tube. In other embodiments, the treatmentdevice 1000 may be used on a first portion of tissue, then moved to asecond portion and used to treat that portion, then optionally moved tothe third portion of tissue, and so on, as desired by the treatingphysician. This technique may be used, for example, to treat an entirecircumference of the Eustachian tube and/or an entire length of theEustachian tube. In yet other embodiments, a different type of tissuetreatment device may be used, which covers and treats an entirecircumference of the Eustachian tube at one time—for example anexpandable balloon energy delivery device. Thus, in various embodiments,any suitable energy delivery device may be used on any suitable portionof Eustachian tube tissue.

FIG. 17 illustrates an embodiment of a method for treating a Eustachiantube. The method may first involve advancing a Eustachian tube treatmentdevice 1010 to a treatment area (e.g., by advancing the treatment device1010 through a nasal passage and into the nasopharynx). The treatmentdevice 1010 may include a shaft 1012, a treatment portion 1014 having atissue treatment surface 1018, and energy delivery members 1016 disposedin an array on the treatment surface 1018. The method may next involvecontacting the tissue treatment surface 1018 with tissue to be treated.The tissue to be treated may be tissue of the nasopharynx at, near, oron the Eustachian tube ostium. Contacting the tissue treatment surface1018 with the tissue to be treated may involve applying force with thetreatment surface 1018 against the tissue to temporarily deform thetissue. As illustrated in FIG. 17, the method may next involve applyingenergy to the tissue to be treated, using the energy delivery members1016. As illustrated, the tissue to be treated includes tissue of thelevator veli palatini muscle. In various embodiments, the energy may bedelivered before, during and/or after the application of force againstthe tissue with the tissue treatment surface 1014. The treated tissuemay retain at least a partially reshaped configuration after thetreatment device is removed from the patient.

FIG. 18 illustrates an embodiment of a method for treating a Eustachiantube with a treatment device 1020. The treatment device 1020 may includea shaft 1022, a treatment portion 1024 having a tissue treatment surface1028, and energy delivery members 1026 a, 1026 b disposed in an array onthe treatment surface 1028. The tissue treatment portion 1024 may becurved or otherwise shaped such that a portion of the tissue treatmentportion 1024 is configured to be inserted into the Eustachian tubeostium. This may facilitate positioning the device near the ostium ofthe Eustachian tube and facilitate treatment. For instance, one or moreof the energy delivery members 1026 b may be located on a portion of thetreatment portion 1024 configured to be inserted into the Eustachiantube ostium, while energy delivery members 1026 a may be located on aportion of the treatment portion 1024 configured to be external to theEustachian tube. In some embodiments, energy delivery members 1026 a and1026 b may correspond to first and second electrodes of a bipolarelectrode pair.

The method of treating the Eustachian tube may involve advancing aEustachian tube treatment device 1020 to a treatment area (e.g., byadvancing the treatment device 1020 through a nasal passage and into thenasopharynx). The method may next involve contacting the tissuetreatment surface 1028 with tissue to be treated. The tissue to betreated may be tissue of the nasopharynx at, near, or on the Eustachiantube ostium. The tissue to be treated may also include tissue within theEustachian tube. Contacting the tissue treatment surface 1028 with thetissue to be treated may involve applying force with the treatmentsurface 1028 against the tissue to temporarily deform the tissue. Asillustrated in FIG. 18, the method may next involve applying energy tothe tissue to be treated, using the energy delivery members 1026. Invarious embodiments, the energy may be delivered before, during and/orafter the application of force against the tissue with the tissuetreatment surface 1024. The treated tissue may retain at least apartially reshaped configuration after the treatment device is removedfrom the patient.

FIGS. 19A and 19B illustrate an embodiment of a method for treating aEustachian tube with a treatment device 1030. The treatment device 1030may include a shaft 1032, a treatment portion 1034 having a tissuetreatment surface 1038, electrodes 1036 disposed in an array on thetreatment surface 1038 and a passive positioner 1039 extending from thetreatment portion 1034. In some embodiments, the electrodes 1036 may bebipolar electrodes. The passive positioner 1039 may be a component sizedand shaped to be inserted into the Eustachian tube ostium to facilitatepositioning the electrodes 1036 around the ostium. The passivepositioner 1039 may be a soft and/or flexible probe that is configuredto enter and align with the ostium. As illustrated, the passivepositioner 1039 is an elongate protrusion with a bulb at its distal endand the electrodes 1036 are disposed on the treatment surfaced 1038circumferentially around the passive positioner 1039. The passivepositioner 1039 may facilitate positioning the device near the ostium ofthe Eustachian tube and facilitate treatment. In other embodiments, thepassive positioner 1039 may include other shapes, such as a conicalshape. In some embodiments, the passive positioner 1039 may includeelectrodes for treatment within the Eustachian tube. In someembodiments, the passive positioner 1039 may include a camera or othervisualization device. In some embodiments, the passive positioner 1039may include a sample-collection feature configured to collect a sample(e.g., a tissue sample). In some embodiments, the passive positioner1039 may include a balloon that may be expanded after the passivepositioner is inserted into the ostium in order to facilitatepositioning, anchoring, and/or treating. The passive positioner 1039 mayinclude other features as well.

As illustrated in FIG. 19A, the method may involve advancing thetreatment device 1030 into a nasopharynx and inserting the passivepositioner into the ostium of the Eustachian tube, thereby positioningthe electrodes around the ostium. As illustrated in FIG. 19B, the methodmay next include contacting the tissue treatment surface 1038 with thetissue to be treated. The tissue to be treated may be tissue of thenasopharynx at, near, or on the Eustachian tube ostium (e.g., submucosalocated just outside the ostium). Contacting the tissue treatmentsurface 1038 with the tissue to be treated may involve applying forcewith the treatment surface 1038 against the tissue to temporarily deformthe tissue. The method may next involve applying energy to the tissue tobe treated using the electrodes 1036.

In some embodiments, the method may further include the step ofinserting a reshaping device into a nasal passageway or an ear canalafter applying an energy or cryotherapy treatment. In such embodiments,a reshaping device such as an external or internal reshaping device maybe applied to the patient after the treatment in order to allow forlong-term reshaping of Eustachian tube and/or surrounding structures asthe treated tissues heal over time.

FIGS. 20A-20D illustrate an embodiment of a device 1100 having anarcuate treatment element 1110 for treating a Eustachian tube. Referringto FIG. 20A, the device 1100 includes the treatment element 1110disposed at a distal end of a shaft 1120. The treatment element 1110includes a treatment surface 1112 having multiple electrodes 1114 and athermocouple 1116 disposed thereon.

In the illustrated configuration, the treatment surface 1112 includes asubstantially flat shape, but other configurations, such as a concaveshape or a convex shape, may be used. The electrodes 1114 are elongate,blunt-tipped electrodes extending from the treatment surface 1112. Theelectrodes 1114 can take other forms, including but not limited toneedle electrodes. The electrodes 1114 can be configured as bipolarelectrodes or monopolar electrodes 1114. The thermocouple 1116 can beconfigured to measure a surface or a sub-surface temperature of thetissue to be treated or tissue near the tissue to be treated.

FIG. 20B illustrates a front view of the treatment element 1110. In thisview, the arcuate shape of the treatment surface 1112 can be seen. Inthe illustrated embodiment, the treatment surface 1112 is configured tohave an arc angle of approximately 112 degrees, though otherconfigurations may be used including arc angles of between approximately102 and 122 degrees. In some embodiments, the treatment surface 1112 mayform a complete circle. The electrodes 1114 are disposed in two,parallel, arcuate rows on the treatment surface 1112.

The electrodes 1114, the treatment surface 1112, and the device 1100 asa whole can be configured (e.g., sized, shaped, or otherwise arranged)to treat tissue of or near the Eustachian tube ostium. The treatmentelement 1110 can define an ostium portion 1118 configured to facilitatetreatment of a Eustachian tube ostium. For example, in the illustratedconfiguration, the treatment element 1110 and treatment surface 1112define an ostium-portion 1118, configured as a space that canaccommodate a typical size and shape of an ostium. During treatment, thetreatment element 1110 can be positioned in a nasopharynx with theostium in the ostium portion 1118 of the treatment element 1110. When soarranged, the arcuate treatment element 1110 is positioned adjacenttissue near the ostium for treatment. While the illustrated ostiumportion 1118 is defined by the treatment element 1110 and lacksmaterial, in other embodiments it need not be so configured. Forexample, in an embodiment, the ostium portion 1118 can include a portionof material without electrodes, insulating material, electrodes fortreating the ostium directly, cooling elements to remove energy from theostium, elements for treating within the Eustachian tube, positioningelements (e.g., a passive positioner as in FIGS. 19A and 19B), or otherelements.

FIG. 20C illustrates a side view of the treatment element 1110. Asillustrated in this view, the treatment element 1110 extends from theshaft 1120, such that treatment surface 1112 is angled relative to theshaft 1120. In the illustrated configuration, a normal of the treatmentsurface 1112 is angled approximately 70 degrees from a longitudinal axisof the shaft 1120 (e.g., angled approximately 70 degrees from parallelwith the longitudinal axis of the shaft). In other embodiments, theangle is between approximately 60 degrees and approximately 80 degreesfrom the longitudinal axis of the shaft 1120. In some examples, a normalof the treatment surface 1112 is approximately perpendicular or parallelto the shaft 1120. In some examples, the configuration of the treatmentelement 1110 relative to the shaft 1120 is configurable by the user. Inthe illustrated configuration, the electrodes 1114 extendperpendicularly away from the treatment surface 1112. In someconfigurations, the electrodes may extend at a different angle.

FIG. 20D illustrates a rear view of the treatment element 1110. Asillustrated, the treatment element 1110 is positioned with a Eustachiantube ostium within the ostium portion 1118 of the treatment element1110. With the device 1100 in this position, the treatment element 1110can be used to treat tissue near the Eustachian tube ostium.

In alternative embodiments, internal and/or external reshaping devicesmay be used to reshape a Eustachian tube or surrounding tissue prior tothe step of applying energy or cryotherapy treatments to target tissue.In some embodiments, the energy or cryotherapy treatment may beconfigured to change the properties of treated tissues, such that thetissues will retain the modified shape within a very short time of thetreatment. In alternative embodiments, the treatment may be configuredto reshape structures over time as the tissue heals.

In some embodiments, a portion of the Eustachian tube and/or associatedtissue may be reshaped using a reshaping device and then fixed intoplace. In some embodiments, such fixation may be achieved by injecting asubstance such as a glue, adhesive, bulking agent or a curable polymerinto a region at or near the Eustachian tube.

In some embodiments, an injectable polymer may be injected into a regionof the Eustachian tube and/or surrounding tissue, either below the skinon the exterior of the face, or under the tissue (e.g., mucosa) of theinterior of the nasopharynx. In some embodiments, an injectable polymermay include a two-part mixture configured to polymerize and solidifythrough a purely chemical process. One example of a suitable injectabletwo-part polymer material is described in U.S. Patent ApplicationPublication 2010/0144996, the entirety of which is hereby incorporatedby reference. In other embodiments, an injectable polymer may requireapplication of energy in order to cure, polymerize or solidify. Areshaping device may be used to modify the Eustachian tube and/orsurrounding tissue before, after, and/or during injection of a polymer.In embodiments employing an energy-curable polymer, a reshaping devicemay include energy-delivery elements configured to deliver energysuitable for curing the polymer to a desired degree of rigidity.

In another embodiment, the muscles of the face are stimulated to modifythe Eustachian tube prior to and/or during application of othertreatments such as energy/cryo application or fixation treatments. Insuch embodiments, the muscles to be treated may include the muscles ofthe soft palate (e.g., the levator veli palatini and tensor velipalatini),muscles of the ear (e.g., tensor tympani), and/or othermuscles affecting the Eustachian tube. In some embodiments, the targetedmuscles may be stimulated by applying an electric current to contractthe muscles, mentally by the patient, or manually by the clinician.

In some embodiments, muscles may also be selectively deactivated throughchemical, ablative, stimulatory, or mechanical means. For example,muscles may be deactivated by temporarily or permanently paralyzing orotherwise preventing the normal contraction of the muscle tissue.Chemical compounds for deactivating muscle tissues may include botulinumtoxin (aka “Botox”), or others. Ablative mechanisms for deactivatingmuscle tissue may include RF ablation, laser ablation or others.Mechanical means of deactivating muscle tissues may include one or moresurgical incisions to sever targeted muscle tissue.

In some embodiments, energy may be applied to the skin of the face toeffect a shrinkage of the skin, epidermis, dermis, subdermal,subcutaneous, tendon, ligament, muscle, cartilage and/or cartilagetissue. The tissue shrinkage is intended to result in a change of forcesacting on the Eustachian tube to improve the Eustachian tube's function.

In another embodiment, the Eustachian tube and/or surrounding tissue maybe damaged or stimulated by energy application, incisions, injections,compression, or other mechanical or chemical actions. Following suchdamage, a device may be used on the tissue to mold or shape the tissueduring healing. In some embodiments, such a reshaping device may betemporarily placed or implanted to hold a desired shape while thepatient's healing process progresses.

In some embodiments, devices may be used to provide tissuereshaping/molding and to impart energy to the Eustachian tube and/orsurrounding tissue. The electrode may be placed in contact with thetarget tissue. The electrodes and molds may be moved to shape the tissueas necessary to achieve improvement in the Eustachian Tube. Theelectrodes may be activated while the tissue is deformed in the newshape to treat the tissue. The electrode may then be deactivated and thedevice may be removed.

If the treatment device includes a monopolar electrode or electrodeneedles, a ground pad may be attached to the patient. The ground pad maybe attached at the patient's torso, for example the shoulder or abdomen.Other locations are also possible, such as the patient's buttocks.Preferably, the point of attachment is a large, fleshy area. After beingattached, the ground pad may be plugged into a power source. If thedevice is powered by a remote generator (e.g., RF generator), the devicemay then be plugged into the generator.

A thermocouple may be provided on the electrode of a treatment element.In some embodiments, more than one thermocouple may be provided. Forexample, in embodiments including more than one electrode or electrodepair, each electrode or electrode pair may include a thermocouple. Thethermocouple may monitor temperature of the electrode and providefeedback to a control unit (e.g., control system 42 described withrespect to FIG. 1). The control unit may use the data from thethermocouple to regulate temperature and auto-shutoff once treatment hasbeen achieved or in the case of an overly high temperature.

After treating the tissue, the device may be removed from, for example,the pharynx and/or ear canal. If a grounding pad is used, the groundingpad may be detached from the patient.

In some embodiments, differential cooling mechanisms may be used totreat the Eustachian tube and/or surrounding tissue using electrodes orother energy delivery elements while maintaining a reduced temperatureat other tissue (e.g., skin and/or mucosa). The cooling system may beactivated. The device may then be in contact with target tissue. Thedevice may then be activated. Activation of the device may cause, forexample, an increase in the cartilage temperature while minimizing thetemperature increase in the skin and/or mucosa. The device may then bedeactivated and removed.

In some embodiments, devices may be used in which insulating material isused to protect non-target tissue during energy delivery. In anembodiment, a device includes an electrode needle preferentiallyinsulated on a portion of the needle. The needle may be inserted intothe cartilage so that the insulated portion is in contact with themucosa and/or the skin and the non-insulated portion is in contact withthe cartilage. The device may be activated, causing an increase in thecartilage temperature while minimizing temperature increase in the skinand/or mucosa. The device may be deactivated and removed.

Additional Embodiments and Features

Referring now to FIGS. 21A and 21B, in one embodiment, a device 900 fortreating a Eustachian tube and surrounding tissue may include aninternal power source and thus be cordless. In the embodiment shown, thedevice 900 includes a handle 902 coupled with a shaft 904, which in turnis coupled with a treatment element 908. The handle 902 may include apower button 910 (or “on/off switch”), a circuit board (912, FIG. 9B)and a space and connections for insertion of batteries 914 as a powersource. Treatment element 904 may include multiple needle electrodes 906for applying RF energy to tissue.

Any suitable features, elements, materials or the like that have beendescribed above may be applied to the device 900 in a similar way. Invarious alternative embodiments, the device 900 may include any number,size or type of batteries, depending on the size of the handle 902 andpower requirements of the device 900. In some alternative embodiments,the device 900 may include an alternative power source. For example, thebatteries 914 may be rechargeable in some embodiments. In otherembodiments, it may be possible to plug the device 900 into a powergenerator for charging, and then unplug the device 900 for use. In yetother alternative embodiments, the device 900 may include a solar powercollection member. The advantage of including an internal power sourcein the device 900 is that this eliminates the need for the device 900 tobe connected, via power cord, to a large, table-top generator, as mostenergy delivery surgical/medical devices require. This allows aphysician to perform a Eustachian tube procedure in any location orpatient orientation without having to manage power cables andgenerators.

In some embodiments, a system for modifying a Eustachian tube mayinclude one or more sensors. Such sensors may be used to sense any of anumber of relevant tissue properties, such as temperature, impedance andthe like. The sensors may be located on a treatment device in someembodiments, or alternatively they may be separate from the treatmentdevice and positioned at or near the device during treatment. In someembodiments, the sensor(s) may provide feedback directly to thetreatment device. For example if a particular tissue temperaturethreshold is reached, a sensor (or sensors) may send a signal to a powergenerator to shut down or decrease power delivered to a treatmentdevice. In alternative embodiment, the sensor(s) may instead providefeedback to a physician or other user, so that the physician or otheruser can make treatment adjustments. For example, sensors may provide awarning signal when a particular tissue temperature or impedance isreached, which will help a physician know when to turn off or decreasepower delivery to a treatment device. Additionally, sensor(s) may beused to sense one or more tissue properties in any suitable tissue ormultiple tissues, such as but not limited to mucosa, cartilage, dermis,epidermis and other types of body soft tissue.

In an alternative embodiment, a sensor device may include a transdermalneedle sensor. In another alternative embodiment, a sensor device may beattached directly to a treatment device. As illustrated by these variousembodiments, sensors may be positioned either at or near a treatmentlocation during a treatment. In some embodiments, for example, a sensormay be placed on or in epidermis while a treatment is being performed onmucosa. Alternatively, a sensor may be placed directly on mucosa duringa treatment of mucosa. Additionally, in any given embodiment, multiplesensors may be placed at multiple different locations in and/or ontissue. As mentioned above, the sensor devices may, in variousembodiments, provide any of a number of different types of feedback,such as feedback to a user, feedback to a power generator, or both.

Referring now to FIG. 22, in some embodiments, a treatment device 950may include a treatment element 952 with wings 954 extending laterallyfrom it. The wings 954 are configured to help direct the treatmentelement 952 into a particular treatment location/position and/or toprevent the treatment element 952 from contacting tissue that thephysician does not want to treat. The wings 954 may be configured tohelp prevent the treatment element 952 from being advanced too far.Alternative embodiments may include additional wings or otherprotrusions or shapes to prevent contact particular structures. Someembodiments may include adjustable wings or wings that expand once theelectrodes have been placed. Any other size, shape or configuration ofone of more wings may be included, according to various embodiments.

Referring to FIGS. 23A-23C, in various alternative embodiments,treatment elements of treatment devices may have different shapes and/orsizes for addressing different types and/or shapes of tissue. Forexample, as shown in FIG. 23A, in one embodiment, a treatment element960 of a device may have a square or rectangular profile with a flatdistal end, which may be ideal for addressing relatively flat tissueconfigurations. Two electrodes 962 (or two sets of electrodes) may beused to send an arc of current (e.g., RF current) through tissue in thepattern shown by the multi-headed arrow.

In another embodiment, as shown in FIG. 23B, a treatment element 970 mayhave an oval profile with a curved distal end. Two electrodes 972 orsets of electrodes send a current through tissue in an arc. Thisconfiguration may be advantageous for addressing tissue having a curvedprofile. In yet another embodiment, as shown in FIG. 23C, a treatmentelement 980 may have a flatter curved profile, for example foraddressing tissue with a curved shape but not as sharp of an angle asthe tissue shown in FIG. 23B. Again, the electrodes 982 send energythrough the curved tissue in a curved arc.

As is evident from FIGS. 23A-23C, a treatment element of a treatmentdevice may have any suitable configuration for advantageously addressingany tissue type and shape. In some embodiments, multiple differenttreatment devices, each having a differently shaped treatment element,may be provided, and a user may select a treatment device for aparticular tissue type and/or shape, based at least in part on the shapeof the treatment element of the device.

In various alternative embodiments, a treatment device for Eustachiantube and surrounding tissue may use a treatment modality that does notinvolve delivery of energy to, or removal of energy from, tissue. Forexample, in some embodiments, the treatment device may create some kindof mechanical injury to one or more tissues to cause a change in shapeand/or one or more properties of the tissue. The expandable balloonembodiment described above is one example. Other examples may include,but are not limited to, needles, micro-needles, blades or the like, anyof which may be used to cause scar tissue formation and/or tissuecontraction. Other embodiments may use sclerotherapy, involvinginjecting one or more substances (acid, coagulants, etc.) into thetarget tissue to induce scar tissue formation and/or other changes inthe tissue properties. In some cases, one type of tissue (for example,mucosa) may be transformed into a different type of tissue altogether(for example, scar tissue). In other examples, a one or more propertiesof the tissue may be changed without changing the overall type oftissue. For example, the tissue may be caused to shrink, contract,stiffen and/or the like. One advantage of these non-energy-basedembodiments is that they do not require a source of energy. This maymake them easier to use and possibly to manufacture and supply.

In other embodiments, thermal energy may be applied to the Eustachiantube or surrounding tissue by applying the energy from an externallocation, rather than an internal location within, for example, anairway of a patient. For example, in some embodiments, a treatmentdevice may be positioned on the skin of a patient and used to deliverthermal energy through the epidermis to the deep subdermal and/or dermallayer near the Eustachian tube or surrounding tissue. In someembodiments, the treatment device may also be used to cool thesuperficial dermis and epidermis, for example. This delivery of energycould, in some embodiments, act to tighten tissue. In an alternativeembodiment, instead of using thermal energy to change the tissues, atreatment device may use mechanical means, such as micro-needles, tocreate a subdermal tissue response, such as scarring, for a similar typeof tissue tightening effect.

In yet other embodiments, some methods for treating a Eustachian tube orsurrounding tissue may include applying a gel, paste, liquid or similarsubstance to a surface of a tissue during an energy delivery treatmentof tissue. Such substances may be applied to target tissue, such asmucosa, non-target tissue, such as epidermis, or a combination of both.The substance (or substances) applied may serve any of a number ofdifferent purposes, such as but not limited to modifying conductivity oftissue and providing anesthetic effect. Conductivity enhancingsubstances may improve the efficiency and/or consistency of energydelivery (such as but not limited to RF energy). Alternatively oradditionally, one or more substances may be injected into tissue. Forexample, saline, Lidocaine, other anesthetic agents, or any othersuitable agents, may be injected. Some embodiments may involve applyingone substance and injecting another sub stance.

In other alternative embodiments, it may be possible to achieve desiredchanges in tissue properties and/or shapes by injecting substance orapplying substance only—in other words, without also applying energy.For example, injecting a sclerotherapy substance into tissue may, insome embodiments, achieve a desired tissue result. In additionalalternative embodiments, a method of treating a Eustachian tube orsurrounding tissue may include injecting a substance into nasal tissueand then curing the substance in order to change the substance'sproperties and, in turn, at least one of the nasal tissue's properties.A treatment device may be used to cure the substance. In someembodiments, the treatment device may be used to deform the targettissue and cure the substance, while the tissue is deformed, so that thetissue retains approximately the same, deformed shape after thesubstance is cured and the treatment device is removed. In anotheralternative embodiment, a surface-based biodegradable agent may beapplied and cured to change the shape of the target nasal tissue.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above, but should be determined only by a fairreading of the claims that follow.

What is claimed is:
 1. A method of treating a Eustachian tube, themethod comprising: contacting an elongate treatment element of atreatment device with a surface tissue in or near the Eustachian tube;and applying energy to or removing energy from at least one of thesurface tissue or an underlying tissue, using the elongate treatmentelement, to modify at least one property of the Eustachian tube, therebytreating the Eustachian tube, wherein the at least one property of theEustachian tube remains at least partially modified after the treatment.